ArticleJournal of clinical pharmacology2026
Leveraging Model Integrated Bioequivalence (MIBE) to Address Regulatory Concerns and Waive Repeat Bioequivalence Studies-A Case Study with Clopidogrel.
Article in Journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Model-Integrated Bioequivalence (MIBE) in Generic Drug Research: Can We Ease the Bioequivalence Burden?Pharmaceutics · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
In recent years, model-informed strategies such as the model integrated bioequivalence (MIBE) approach have gained significance due to their ability to enable decision making, streamline drug product development, and to waive bioequivalence studies, as applicable. In this work, we demonstrate the successful application of the MIBE approach that led to the waiver of a repeat fasting and fed bioequivalence studies for clopidogrel bisulfate 300 mg tablets. In the pivotal bioequivalence study, pharmacokinetic sampling in fasting and fed conditions was performed until 12 h, shorter than the recommended sampling up to at least three half-lives of the drug. The mean half-life of reference listed drug clopidogrel was 6 h. During dossier review, a query was received from the regulatory agency to assess the impact of early termination of the study on AUC
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Registered trials
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